Cleared Traditional

PMT Facet Fixation System, Lumbar (PMT FFS-LX)

K230840 · Providence Medical Technology, Inc. · Orthopedic
Dec 2023
Decision
267d
Days
—
Risk

About This 510(k) Submission

K230840 is an FDA 510(k) clearance for the PMT Facet Fixation System, Lumbar (PMT FFS-LX), a System, Facet Screw Spinal Device, submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 19, 2023, 267 days after receiving the submission on March 27, 2023. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K230840 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2023
Decision Date December 19, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —